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The HAMILTON-C3 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants, and neonates.

Intended areas of use:

• In the intensive care ward or in the recovery room.
• During transfer of ventilated patients within the hospital.

The HAMILTON-C3 ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician and within the limits of its stated technical specifications.

The HAMILTON-C3 has been designed to ventilate adult and pediatric patients in the critical care environment. With optional support, the HAMILTON-C3 is also able to ventilate infants and neonates. The HAMILTON-C3 ventilator uses the same graphical user interface (GUI) used by the predicate HAMILTON-C2, which features a touchscreen "Ventilation Cockpit". This provides the exact information that the user needs and helps focus on what is important. In addition, the HAMILTON-C3 includes the ASV ventilation-mode, which automatically applies lung-protective strategies, reduces the risk of operator error, and promotes early weaning.
The HAMILTON-C3 has been designed with built-in batteries and a turbine thereby giving the user maximum independence and flexibility to accompany a patient everywhere. The HAMIL-TON-C3 offers the same ventilation modes as the HAMILTON-C2, which provides for both full and partial ventilatory support.

1. The HAMILTON-C3 offers all the conventional modes, as well as advanced invasive and non-invasive ventilation modes: ASV, (S)CMV+, SIMV+, PCV+, SPONT, APRV, DuoPAP, NIV, NIV-ST, nCPAP-PS, PSIMV+, and PSIMV+ with IntelliSync.
2. All 41 monitoring parameters can be trended over 1, 6, 12, 24, and 72 hours.
3. The ability to turn off the Apnea alarm in the nCPAP-PS mode.
4. The HAMILTON-C3 includes a 12.1" wide-screen monitor.

The Hamilton-C3 is a continuous ventilator. The provided text outlines its characteristics, intended use, and a comparison with a predicate device and other FDA-cleared ventilators. However, it does not include detailed acceptance criteria or a study that specifically "proves the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device with performance metrics like sensitivity, specificity, or F1-score.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel performance. The "acceptance criteria" discussed are primarily related to safety, effectiveness, and adherence to recognized standards, rather than specific performance metrics for a novel diagnostic function.

Here's a breakdown based on the information provided, and where information is not present:

1. Table of acceptance criteria and the reported device performance

Based on the document, "acceptance criteria" are inferred from the demonstration of substantial equivalence and adherence to recognized standards. The "reported device performance" is largely presented as meeting the same functional capabilities as the predicate device (HAMILTON-C2) and adhering to various medical device standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable in the traditional sense for this submission type. This is a 510(k) submission based on substantial equivalence, not a clinical trial with a "test set" of patient data to evaluate a diagnostic algorithm's performance. The "testing" referred to is non-clinical verification and validation of the device's functionality and adherence to standards. There is no mention of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. As per point 2, there is no "test set" with ground truth in the context of diagnostic performance presented in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This document describes a continuous ventilator, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a medical device (ventilator), not a standalone algorithm. While it contains software, the evaluation in this document focuses on the integrated system's safety and effectiveness and its equivalence to a predicate device, not on the performance of a standalone algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. As per point 2, there is no "test set" requiring ground truth for diagnostic performance evaluation. The "ground truth" for the device's functionality is its design specifications and compliance with recognized standards.

8. The sample size for the training set

• Not Applicable. This document does not describe the development or evaluation of an AI/ML algorithm that would require a "training set" of data.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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